UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 14, 2012
_________________
22nd Century Group, Inc.
(Exact Name of Registrant as Specified in Charter)
| Nevada | 000-54111 | 98-0468420 |
|
(State or Other Jurisdiction of
Incorporation) |
(Commission File Number) |
(I.R.S. Employer
Identification No.) |
|
9530 Main Street Clarence, New York (Address of Principal Executive Office) |
14031 (Zip Code) |
|
|
Registrant’s telephone number, including area code: (716) 270-1523 |
||
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 1.01 Entry into a Material Definitive Agreement.
On August 14, 2012, 22nd Century Limited, LLC (the “Company”), a wholly owned subsidiary of 22nd Century Group Inc., entered an agreement (the “Amendment”) amending the Company’s exclusive worldwide license agreement (“License Agreement”) with North Carolina State University. The material terms of the Amendment are as follows: (i) extension by three (3) additional years of the dates of various milestones to be fulfilled by the Company; (ii) extension of the term of the License Agreement by more than two (2) additional years to September 16, 2023; and (iii) clarification and confirmation that six (6) previously granted patents, among others, have been and continue to be part of the License Agreement.
The foregoing description of the Amendment is not complete and is qualified in its entirety by reference to the Amendment, which is attached hereto as Exhibit 10.1 and incorporated herein by this reference.
Item 9.01 Financial Statements and Exhibits
| (d) | Exhibits |
| 10.1 | First Amendment to the Exclusive License Agreement between North Carolina State University and 22nd Century Group Inc. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| 22nd Century Group, Inc. | ||
| /s/ Joseph Pandolfino | ||
| Date: August 20, 2012 |
Joseph Pandolfino Chief Executive Officer |
|
AMENDMENT
This first Amendment to the Exclusive License Agreement between NORTH CAROLINA STATE UNIVERITY (“ NCSU ”) and 22nd CENTURY LIMITED, LLC (“ LICENSEE ”) executed March 6, 2009 (the “Agreement”) is entered into on the 9th day of August 2012, (“Amendment Effective Date”).
WHEREAS, on June 22nd, 2009 the Family Smoking Prevention and Tobacco Control Act was enacted granting the U.S. Food and Drug Administration (“FDA”) regulatory control over all tobacco products; and
WHEREAS, Licensee has initiated a program for commercial development of a Licensed Product that is a Smoking Cessation Aid under Investigational New Drug application 103,589 filed with the FDA and completed a 238 subject Phase II trial in 2012; and
WHEREAS, as of the Amendment Effective Date, Licensee’s research, development and commercialization of Licensed Products, including that of its former sublicensee, have satisfied Licensee’s due diligence obligations; and
WHEREAS NCSU and LICENSEE, (collectively “the Parties”) wish to amend the Agreement; and
NOW THEREFORE , in consideration of the mutual covenants set forth herein, the Parties hereby agree as follows:
| 1. | The Agreement is amended as follows: |
| (a) | Paragraph 1.03 of the Agreement is amended to read as follows: |
| 1.03 | “Materials(s)” means Vector 21-41 seed covered by Plant Variety Protection Certificate No. 200100039 in the U.S., together with any progeny, mutants, derivatives, or replicated forms thereof, and all cells or plant tissues containing such material, including any replicated and derivative forms thereof. |
| (b) | The last sentence of Paragraph 4.01 is amended to read as follows: |
Variations from Appendix C must be expressly approved by NCSU in writing, such approval not to be unreasonably withheld including that NCSU shall consider that factors causing such delays may be regulatory in nature and may be beyond the control of the Licensee.
| (c) | The last two sentences of Paragraph 4.02 are amended to read as follows: |
Should Licensee anticipate not meeting any such Development/Commercialization milestones, it may outline the reasons in writing to NCSU prior to the deadline and request a reasonable extension of time or amendment of the milestone. NCSU shall reasonably consider any such request from Licensee.
| (d) | The first sentence of Paragraph 10.01 of the Agreement is amended to read as follows: |
10.01 – Term . This Agreement shall become effective upon the Effective Date and, unless sooner terminated in accordance with any of the provisions herein, shall remain in full force and effect until the date of expiration of the last to expire of the Patent Rights or the expiration of Plant Variety Protection Certificate No. 200100039, whichever is later; provided however, that in those countries in which no patent contained in the Patent Rights issues, this Agreement shall expire in such countries upon the earlier of (i) ten (10) years after the first commercial sale of a Licensed Product or (ii) December 31, 2019 (the “Term”).
| (e) | Licensee’s address provided in Article 12 is amended to read as follows: |
22nd Century Limited, LLC
Attn: Joseph Pandolfino
9530 Main Street
Clarence, NY 14031
| (f) | The address provided in 12.03 is amended to read as follows: |
22nd Century Limited, LLC
c/o Foley & Lardner LLP
3000 K Street, N.W., Sixth Floor
Washington, D.C. 20007
| (g) | Appendix A is amended to include the following Patent Rights: |
| (h) | The three milestones of Appendix C are amended to read as follows: |
December 31, 2013 – Licensee will have initiated a phase III clinical trial for a Licensed Product that is a Smoking Cessation Aid.
December 31, 2014 – Licensee will have applied for FDA approval for sale of a Licensed Product that is a Smoking Cessation Aid.
December 31, 2015 – Licensee will have completed first commercial sale of Licensed Product that is a Smoking Cessation Aid.
| (g) | Appendix D is amended to read as follows: |
APPENDIX D
ROYALTY REPORT FORM
22nd Century Limited, LLC Agreement Royalty Report for the Period ____________through___________.
Instructions: Please fill in all boxes (write "none" if not applicable), and sign and date at bottom.
Prod.#_________ Prod. Name: ___________________
NCSU Patents: ___________________
Please provide patent numbers and patent application numbers of all NCSU patents related to this product.
Government Approvals: ___________________
Date of First Commercial Sale: ___________________
| Country | Gross Billings | Deductions | Type of Deduction | Net Sales | Royalty Rate | Royalties Due |
| Subtotal for Product | ||||||
Prod.#_________ Prod. Name: ___________________
NCSU Patents: ___________________
Please provide patent numbers and patent application numbers of all NCSU patents related to this product.
Government Approvals: ___________________
Date of First Commercial Sale: ___________________
| Country | Gross Billings | Deductions | Type of Deduction | Net Sales | Royalty Rate | Royalties Due |
| Subtotal for Product | ||||||
USE ADDITIONAL SHEETS FOR ADDITIONAL PRODUCTS.
Total amount enclosed $_______________
22nd Century Limited, LLC
By: Date:
Name and Title: ________________________________
| 2. | All terms and conditions of the Agreement not specifically modified by this Amendment remain in full force and effect. |
IN WITNESS WHEREOF , the Parties hereto have executed this Amendment on the dates set forth below.
| NORTH CAROLINA STATE UNIVERSITY | 22nd CENTURY LIMITED, LLC |
| /s/ Billy B. Houghteling | /s/ Joseph Pandolfino |
| Billy B. Houghteling | Joseph Pandolfino |
| Executive Director | Chief Executive Officer |
| Date: August 9, 2012 | Date: August 14, 2012 |